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Recall Observatory FDA recall evidence

Device product

Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.

Z-0596-2018

August 28, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79103
Status
Terminated
Classification
Class II
Quantity
1,275 units total
Official record key
device-enforcement:Z-0596-2018

Official wording

Reason: Potential for the Persona Partial Knee Impactor Pad to fracture.

Code information: Item No. 42539909100; Lot No. (UDI No.): 63517759 ((01) 00880304810242 (10) 63517759), 63555750 ((01) 00880304810242 (10) 63555750), 63555752 ((01) 00880304810242 (10) 63555752), 63561883 ((01) 00880304810242 (10) 63561883), 63561884 ((01) 00880304810242 (10) 63561884), 63594911((01) 00880304810242 (10) 63594911), 63594914 ((01) 00880304810242 (10) 63594914), 63698564 ((01) 00880304810242 (10) 63698564), 63705328 ((01) 00880304810242 (10) 63705328)

Distribution pattern: US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the Persona Partial Knee Impactor Pad to fracture.